Nickel Sulfate, Potassium Bromide, Sodium Bromide, Zinc Sulfate Anhydrous, And Sulfur

Description

DESCRIPTION Acunol™ is a biochemical homeopathic medication indicated for the treatment of acne. 32-34 The active ingredients in each Acunol™ tablet consist of the following: Potassium Bromide (Kali Bromatum) 1X, Sodium Bromide (Natrum Bromatum) 1X, Zinc Sulphate (Zincum Sulphuricum) 1X, Sulphur 1X, and Nickel Sulphate (Niccolum Sulphuricum) 1X. These drug ingredients are listed in the Homoeopathic Pharmacopoeia of the United States (HPUS). 1 Inactive ingredients: Lactose, Magnesium Stearate, and Copper (II) Oxide. Pharmacological class: Homeopathic drug. Dosage form: Oral 600 mg scored tablet. May be swallowed whole, chewed or dissolved in the mouth and swallowed.

What Is Nickel Sulfate, Potassium Bromide, Sodium Bromide, Zinc Sulfate Anhydrous, And Sulfur Used For?

INDICATIONS Acunol™ is indicated for the treatment of mild to moderate acne vulgaris, acne rosacea, peri-oral dermatitis, and folliculitis. It has been found to work well with a variety of combination therapies.

Dosage and Administration

DOSAGE AND ADMINISTRATION Take tablets twice a day (b.i.d.) for best results. Absorption of nickel sulphate is variable among individuals. For maximum nickel absorption, tablets should be taken orally upon rising at the beginning of the day and at the end of the day before bed. Take nothing but water for one hour after taking medication to aid nickel absorption. If taking Tetracycline or Levofloxacin allow at least two hours after taking Acunol. If taking a different Quinolone antibiotic, consult manufacturer's information. Kg lbs Starting dose Max Daily dose 23-45 51-100 ½ ∙ b.i.d. 1 ∙ b.i.d. 46-68 101-150 1 ∙ b.i.d. 2 ∙ b.i.d. 69-90 151-200 1½ ∙ b.i.d. 3 ∙ b.i.d. 91+ 201+ 2 ∙ b.i.d. 4 ∙ b.i.d. Increase dose only if needed on a monthly basis up to the max daily dose. Treatment dose and duration depends on the individual. In the setting of significant renal impairment Dosage should be adjusted and serum nickel and bromide levels should be followed. Steady state trough nickel level should be drawn prior to ingesting the day's dose after one week of dosing or at appropriate intervals. Target trough serum nickel level is 10-40 mcg/L. (Caution: post dose peak levels are unreliable.) Serum bromide assay by spectrophotometry is the historic standard. 36 Concentrations higher than 50 mg/dl may be compatible with toxicity. No therapeutic target levels exist for bromide.

Side Effects (Adverse Reactions)

ADVERSE REACTIONS Acunol™ contains low doses of active ingredients. Therefore there are minimal known side effects. (see PRECAUTIONS for hypersensitivity information)

Drug Interactions

Drug interactions There are no known drug interactions. Since copper deficiency in human nutrition has occasionally been induced by supplemental zinc therapy, copper has been added in order to minimize this rare occurrence. (see Inactive ingredients ) For Tetracycline or Quinolones co-administration with Acunol, see Dosage and Administration

Contraindications

CONTRAINDICATIONS Although there are no known contraindications, patients who are allergic to any Acunol™ ingredient should consult a physician prior to taking the medication. (Refer to Section on Hypersensitivity )

Pregnancy and Breastfeeding

Pregnancy Pregnancy category C Animal reproduction studies have not been conducted with Acunol™. Acunol™ should not be given to a pregnant woman.

Nursing mothers It is not known whether this drug is excreted in human milk. However, since many drugs are excreted in human milk, caution should be exercised when Acunol™ is administered to a nursing woman.

Overdosage

OVERDOSAGE Bromide toxicity Indications of toxicity due to oral overdosage of bromide may include nausea, vomiting, apathy, disturbed coordination, loss of memory, drowsiness, loss of emotional control, agitation, hallucination, tremors, depressed reflexes, stupor, and coma. Acute toxic reactions in humans have been reported at doses as low as 1000 mg. 19 This level is 33 times the dose received in one tablet of Acunol™. Zinc sulphate toxicity Symptoms of acute toxicity of zinc due to oral overdoseage can include dehydration, stomach pain, lethargy, dizziness, muscular incoordination, and in severe cases renal failure. 26 Chronic zinc toxicity can occur at levels of 100-300 mg/d. 30 Sulphur toxicity The oral rat LD 50 for sulphur is reported to be greater than 5,000 mg/kg. 23 This is more than 11,000 times the maximum dose recommended for Acunol™. Ingestion of toxic levels of sulphur can cause sore throat, nausea, headache, gastrointestinal irritation, and possibly unconsciousness in severe cases. 24,25 Sulphur poses such a remote risk that is placed in the lowest toxic category possible, EPA Toxicity Category IV. 23 Nickel sulphate toxicity The oral rat LD 50 for nickel sulphate hexahydrate is 275 mg/kg. 17 Symptoms of toxicity due to oral overdosage of nickel sulphate may include nausea, vomiting, abdominal discomfort, diarrhea, giddiness, lassitude, headaches, cough, and shortness of breath. 18 The lowest observed transitory toxic effects from human ingestion of soluble nickel salts is approximately 8 mg nickel/kg body weight. 18 This is 180 times the maximum dose recommended for Acunol™. (See below )

How Supplied

HOW SUPPLIED Scored tablets, off white in color with green speckles, with imprinted on one side and a score on the other side , in child-resistant and tamper-resistant bottles of 90. NDC 61480-137-05 Symbol